CLS takes next step towards CE marking in neurosurgery by obtaining ISO certificate according to MDR and completion of study at Skåne University Hospital
Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS or the "Company") today announces that the company has received ISO certificate in accordance with the new Medical Device Regulation (MDR) and that the follow-up of patients in the CLS-sponsored clinical study at Skåne University Hospital has now been completed. The company has thus achieved two very important milestones on the way to a market approval of the ClearPoint Prism® Neuro Laser Therapy System in Europe.
CLS has obtained ISO certificate in accordance with MDR
The change in the new Medical Device Regulation (MDR) places increased and clearer demands on manufacturers of medical devices. The aim is for users and patients to have access to safer and more efficient products. After adapting its quality system and processes, CLS has received ISO certificate in accordance with MDR, which means that CLS's operation is approved for the development, manufacture and sale of medical devices which is fundamental for CLS to continue to be able to apply for CE marking of new products and indications.
Completing clinical study on treatment of glioblastoma at Skåne University Hospital
A total of 14 patients with glioblastoma have been treated and followed up after MRI-guided laser ablation. The study, sponsored by CLS and co-funded by CLS partner ClearPoint Neuro Inc., was a single-center, non-randomized prospective study aimed at evaluating the safety and feasibility of minimally invasive MRI-guided laser ablation (Laser Interstitial Thermal Therapy or LITT) of tumor tissue in patients with glioblastoma.
The team at Skåne University Hospital carried out the treatments with the complete solution for MRI-guided laser ablation in neurosurgery co-developed by CLS and ClearPoint Neuro Inc. and which is already successfully marketed and sold in the US by ClearPoint Neuro Inc. under the brands ClearPoint Prism® Neuro Laser Therapy System and ClearPoint® Neuro Navigation System.
Chief physician Peter Siesjö, who is the principal investigator for the study, comments - "In summary, the study could be carried out as planned and a preliminary assessment show that the method is safe and feasible for patients and caregivers. The side effects are considered to be fewer and milder than those seen after open surgical treatment of glioblastoma, which is the most common alternative to laserthermia treatment."
Compilation of the study report, manuscript and abstract for publication in scientific journals and presentations at international conferences is ongoing.
The next step is towards a CE marking in Europe
With these two crucial milestones achieved, CLS can take the next step towards CE marking and market approval of the ClearPoint Prism® Neuro Laser Therapy System on the European market.
For more information, please contact:
Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0) 70-590 11 40
E-post: [email protected]
About CLS
Clinical Laserthermia Systems AB (publ), develops and sells TRANBERG®|Thermal Therapy System and ClearPoint Prism Neuro Laser Therapy System with sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The products are marketed and sold through partners for image-guided laser ablation and are used in studies for treatment with imILT®, the company's interstitial laser thermotherapy for immune stimulating ablation with potential abscopal treatment effect. CLS is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States and a marketing company in Singapore. CLS is listed on Nasdaq First North Growth Market under the symbol CLS B. Certified adviser (CA) is FNCA Sweden AB.
For more information about CLS, please visit the Company's website: www.clinicallaser.se
